Fractyl Health completes randomization in REMAIN-1 pivotal trial for Revita; topline data expected early Q4 2026

FRACTYL HEALTH, INC.

Randomization completed in double-blind, sham-controlled REMAIN-1 study for Revita in weight maintenance after GLP-1 therapy discontinuation.
Topline 6-month pivotal data expected early Q4 2026; potential FDA marketing submission late Q4 2026.
Cash runway reiterated into early 2027, beyond pivotal readout.
Anticipated milestones: Q2 2026 FDA feedback on De Novo pathway, 1-year data from REVEAL-1 and REMAIN-1 Midpoint Cohort.

This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.